FDA Certification Process and Fees Explained: A Must-Read Guide for Amazon Sellers

80%'s cross-border e-commerce sellers get the first step wrong when applying for FDA certification! FDA certification is not new to many Amazon sellers, as the platform mandates FDA test reports and registration numbers for many product categories when they are listed on the Amazon platform.

As one of the world's most authoritative food and drug regulatory agencies, the U.S. FDA has a global reach. Every U.S. consumer's daily life is closely tied to the FDA's oversight. What really helps you understand is that many countries around the world seek the FDA's expertise to improve the safety standards of their domestic products.

FDA certification is divided into two key parts: testing and registration. Medical devices, cosmetics, and food and drug products all require FDA registration. Although it is possible to apply directly on the FDA official website, in order to improve efficiency and avoid prolonging the registration cycle due to failure of the audit, it is recommended to contact a professional third-party testing organization to help solve the registration problems in a one-stop manner.

The FDA's regulatory scope is extremely broad, including the supervision and inspection of food, drugs (including veterinary drugs), medical devices, food additives, cosmetics, animal food and drugs, and even wine beverages with an alcohol content of less than 7%, as well as electronic products. Not all products require FDA approval, but these specific categories of products related to personal health and safety must be certified as safe by the FDA before they can be legally sold in the U.S. market.

What we commonly refer to as FDA approval actually consists of the following major categories:

1. FDA Testing of Food Contact Materials
2. FDA Registration of Laser Products
3. Medical Device FDA Registration
4. Cosmetics and Household Products FDA Inspection Reports
5. FDA Registration for Food, Drugs, Cosmetics and Household Goods

If you want to apply for FDA certification, you can contact a professional agency, the steps are very detailed:

1. Provide complete product information to determine the best route to application
2. Fill out the FDA application form
3. Sign the contract and pay the agency fee
4. Payment in US dollars to the official FDA account
5. Submit registration application information to FDA for approval.
6. Registration Approval Completed, Approval Number Obtained
7. Issuance of Certificate of Registration
8. The whole process takes about 2 weeks

Did you know? Chinese applicants for FDA registration must appoint a U.S. organization as an agent to take care of the service process within the U.S. This is a key aspect that many cross-border sellers tend to overlook. This is a critical aspect that many cross-border sellers tend to overlook. Professional testing organizations often have the resources of U.S. agents to efficiently resolve registration issues.

The most people fall through the glasses is that the FDA does not issue any product certificates, the so-called FDA certificates on the market are issued by the agency's own service certificates. In addition, the FDA will randomly inspect factories in each financial year, and enterprises can not refuse the FDA factory inspection, audit requirements are usually very strict, it is recommended that enterprises are well prepared in advance.

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#FDA Registration Process # Amazon Global Store # Cross-border E-commerce Sellers # Taiwan Manufacturers # U.S. Market Entry # Product Compliance # Cross-border Brands # International Certification #FDA Fee